To improve the healing rate and decrease wound surface area (WSA) of chronic diabetic foot ulcers using ESWT in combination with standard care. Furthermore, this study will investigate the long-term effects of ESWT on ulcer recurrence.
ID
Source
Brief title
Condition
- Diabetic complications
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is percentage of reduction in wound surface area
Secondary outcome
Secondary endpoints are time to complete healing, recurrence rate and quality
of life.
Background summary
Recently Extracorporeal Shockwave Therapy (ESWT) appeared to be an effective
complementary treatment for patients with chronic diabetic foot ulcers in
addition to the standard care. ESWT is a non-invasive and low-cost method for
stimulating wound healing. Some promising previous studies found a higher
healing rate (re-epithelization index) in the patient group that received
standard care + ESWT compared to standard care only. However, these studies
were limited clinical trials (low amount/small number of subjects, no placebo
intervention, only single blinded), with low level of evidence.
Study objective
To improve the healing rate and decrease wound surface area (WSA) of chronic
diabetic foot ulcers using ESWT in combination with standard care. Furthermore,
this study will investigate the long-term effects of ESWT on ulcer recurrence.
Study design
The study will be a double-blind randomized placebo-controlled clinical trial
conducted within the Erasmus Medical Center (EMC) in Rotterdam. The ESWT
treatments will be given by a physiotherapist from Fysio&Shockwave. Patients
will receive 12 (placebo) ESWT treatments once a week. Follow-up will continue
after the last ESWT treatment at 6, 12, and 24 weeks to evaluate the long term
effects of ESWT. Total duration of the study will be 36 weeks. A pilot will be
conducted to optimize the research protocol.
Intervention
The patients will receive 12 (placebo) ESWT treatments in addition to standard
care. Standard care includes debridement, diabetic control, wound care,
off-loading and footwear modification for pressure reduction.
Study burden and risks
In previous studies ESWT was found to be an effective and safe treatment for
patients with chronic diabetic foot ulcers in addition to standard care. ESWT
is a non-invasive therapy with negligible side effects, no anesthesia is
needed, people can still walk and the effects are long lasting. Therefore, we
believe there are minor risks in using ESWT treatments to improve the healing
of diabetic chronic foot ulcers and we can consider ESWT a safe method. We only
need 1 blood sample at baseline and 15 visits to the outpatient clinic will be
necessary when participating in this study. As patients with an ulcer normally
have to come in every 2 or 3 weeks, and we will see them twice more after the
ulcer is healed, a patient with an ulcer that is closed at 12 weeks would
normally attend our outpatient clinic 6 to 8 times. We ask the participants to
fill out the SF-36 questionnaire 3 times. *
Wilhelmina van Pruisenlaan 141
Rotterdam 2807KH
NL
Wilhelmina van Pruisenlaan 141
Rotterdam 2807KH
NL
Listed location countries
Age
Inclusion criteria
• Age 18 years or older
• Diabetes mellitus type I or 2
• Uni- or bilateral chronic foot ulcers which have not healed for 6 weeks
• Grade 1A or 2A ulcer according to the Texas Diabetic Foot Wound
Classification System
• Diameter of the ulcer > 0.5 cm and < 5 cm on the plantar side of the foot
• Ankle-brachial index > 0.7
• Toe systolic pressure > 50 mmHg
• Participants are mentally competent to understand and sign a Dutch informed
consent form themselves
Exclusion criteria
• History of neoplasia or malignancy near the chronic diabetic foot ulcer
• Pregnancy
• Skeletal immaturity which has an influence on the ability to walk
• Sign of acute local infection demanding the use of systemic antibiotics or
the need for amputation
• Osteomyelitis or gangrene in the affected extremity
• Severe anemia (Hb < 7,0g/dl)
• Ankle brachial index < 0.7
• Toe systolic pressure < 50 mmHg
• Any history with ESWT
• Two missed ESWT treatments
• Participation in an ongoing other clinical trial
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66337.078.20 |